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Search / Trial NCT06635980

Hypofractionated Radiotherapy Before or After Breast Surgery for Treatment of Patients With Non-Metastatic Breast Cancer

Launched by MAYO CLINIC · Oct 9, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating how effective a type of radiation therapy called hypofractionated radiotherapy is when given either before or after surgery for women with non-metastatic breast cancer. Non-metastatic means that the cancer has not spread beyond the breast. The goal is to see if this treatment can help patients while also reducing the time they spend receiving therapy and minimizing side effects. Hypofractionated radiotherapy involves giving larger doses of radiation but fewer treatments, which has shown promising results in earlier studies.

To participate in this trial, women aged 18 and older with confirmed breast cancer at various stages (from T1 to T4) may be eligible. They should also be able to provide written consent and complete necessary tests. Participants will undergo treatment and monitoring to assess how well the hypofractionated radiotherapy works and what side effects they may experience. It's important to note that certain health conditions or previous treatments might prevent someone from joining the study. Overall, this trial aims to explore if this approach to radiation can lead to better outcomes for breast cancer patients while being safer and more convenient.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Age \>= 18 years
  • Histological confirmation of breast cancer
  • Clinical stage T1-T4 N0-3 M0
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
  • Able to and provides Institutional Review Board (IRB)-approved study specific written informed consent
  • Able to complete all mandatory tests listed in the trial
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  • Indications for radiotherapy for breast cancer
  • Exclusion Criteria:
  • Medical contraindication to receipt of radiotherapy
  • Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent in the judgment of the principal investigator
  • Active systemic lupus or scleroderma
  • Pregnancy
  • Women of childbearing potential who are unwilling to employ adequate contraception
  • Prior receipt of ipsilateral breast or chest wall radiation
  • Recurrent breast cancer

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Scottsdale, Arizona, United States

Patients applied

0 patients applied

Trial Officials

Carlos E. Vargas, MD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported